Forceps Cliprack Ventricular Cannula Saws Spatulas

FDA 510(k) K874962 · Solway, Inc.

Substantially Equivalent

510(k) numberK874962

Submission

Device name
Forceps Cliprack Ventricular Cannula Saws Spatulas
Applicant
Solway, Inc.
Hollywood, FL, US
Received
December 2, 1987
Decision date
February 2, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HAO – Instrument, Surgical, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 882.4535
Specialty
Neurology

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More from Redmond Neurosurgical, Inc.

510(k)DeviceDecision
K874960Cardiovascular Surgical InstrumentsDWS · Traditional 02/05/1988SE
K874956Self-Retaining Retractor for NeurosurgeryGZT · Traditional 01/28/1988SE
K874964Dental Hand InstrumentsEKJ · Traditional 01/27/1988SE
K875043Rongeur (Neurosurgical Instruments)HAE · Traditional 01/22/1988SE
K874966Tuning ForksGWX · Traditional 01/04/1988SE
K874965Manual Surgical Instruments for General UseHTD · Traditional 12/30/1987SE
K874961Bone Cutting Instruments & AccessoriesGDR · Traditional 12/30/1987SE
K874959Vascular ClampHXD · Traditional 12/30/1987SE
K874954Manual RongeurHTX · Traditional 12/30/1987SE
K874952Manual Cranial Drill, Burr, Trephine & AccessoriesHBG · Traditional 12/30/1987SE

Questions and answers

When was Forceps Cliprack Ventricular Cannula Saws Spatulas cleared by the FDA?

Forceps Cliprack Ventricular Cannula Saws Spatulas (K874962) received a 510(k) decision of Substantially Equivalent on February 2, 1988, 62 days after the submission was received.

What is the product code of K874962?

The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.